RALEIGH, N.C.--(BUSINESS WIRE)--DARA BioSciences, Inc. (NASDAQ: DARA)
DARA BioSciences, Inc. (Nasdaq:DARA) announced today that it has entered into an exclusive distribution agreement with Seyer Pharmatec Inc. for the sale and distribution of Soltamox® (tamoxifen citrate, oral solution) in the Commonwealth of Puerto Rico. DARA plans to launch Soltamox later this year.
Dr. David J. Drutz, DARA's chief executive officer, stated: "The exclusive agreement with Seyer Pharmatec to sell and distribute Soltamox in Puerto Rico leverages DARA's existing commercial infrastructure, provides DARA with a well-respected and established commercial partner, and presents an opportunity to make Soltamox and potential future cancer-support products readily available for patients in this important market. Since DARA has exclusive rights to market Soltamox in the United States and its territories and possessions, our partnership with Seyer Pharmatec will help us maximize Soltamox sales.”
Soltamox is the first and only FDA-approved oral liquid formulation of tamoxifen citrate, a first-line therapy for the prevention and treatment of breast cancer. A significant number of breast cancer patients may have difficulty swallowing pills. This leads some patients to crush pills, mix them with food, or miss doses. Due to difficulty swallowing solid tablets, some patients may discontinue therapy altogether. The availability of liquid tamoxifen offers women with breast cancer a convenient, comfortable and easy-to-swallow alternative.
Seyer Pharmatec is focused on acquiring or in-licensing innovative pharmaceutical products, such as Soltamox, for the Puerto Rico market. With a seasoned national sales force and fully integrated distribution services, Seyer is recognized as a leading specialty pharmaceutical company in Puerto Rico.
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA sharpened its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®. Soltamox is a novel oral liquid formulation of tamoxifen citrate, a product used widely in the treatment and prevention of breast cancer. Soltamox is the only FDA approved oral liquid version of tamoxifen citrate and fulfills a vital clinical need for patients who cannot tolerate existing solid tablet formulations of this drug. DARA plans to begin marketing Soltamox in the U.S. later this year. Additionally, in June 2012 DARA launched its first product, Bionect®, a topical treatment for skin irritation and burns associated with radiation therapy.
Prior to acquiring Oncogenerix, DARA was focused on the development of a cancer-support therapeutic compound, KRN5500, for the treatment of neuropathic pain in patients with cancer. This product is an excellent fit with DARA’s strategic oncology focus, has successfully completed a Phase IIa study, and has been designated as a Fast Track Drug by the United States Food and Drug Administration. DARA is working with the National Cancer Institute (NCI) to design an additional clinical trial under joint DARA-NCI auspices while considering further Phase 2 development.
In addition to its oncology products, DARA’s pipeline includes DB959, a novel, non-TZD dual delta/gamma, PPAR agonist for the treatment of type 2 diabetes and dyslipidemia. DARA has completed Phase I testing of DB959 and is presently pursuing opportunities to out-license this product.
DARA also has rights to other PPAR and DPPIV-inhibitor compounds for which it intends to seek out-licensing or partnering opportunities.
For more information please visit our web site at www.darabio.com.
Safe Harbor Statement
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Bionect®, Soltamox® or other products given that DARA only recently hired its initial sales force and DARA's lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA's ability to market Bionect, Soltamox® or other products in the U.S. or elsewhere, DARA's ability to develop and bring new products to market as anticipated, DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property and the intellectual property of others, the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to successfully integrate Oncogenerix and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.